Paracetamol Mylan Italia

Patient Information Leaflet

Paracetamolo Mylan Italia 500 mg granules

paracetamolo
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days of treatment.

Contents of this leaflet:

1. What Paracetamolo Mylan Italia is and what it is used for
2. What you need to know before taking Paracetamolo Mylan Italia
3. How to take Paracetamolo Mylan Italia
4. Possible side effects
5. How to store Paracetamolo Mylan Italia
6. Contents of the pack and other information

1. What Paracetamolo Mylan Italia is and what it is used for

Paracetamolo Mylan Italia contains the active substance paracetamol, which acts as an analgesic (relieves pain) and antipyretic (reduces fever).
Paracetamolo Mylan Italia is indicated for the relief of pain in the following conditions:

• headache;
• nerve pain (neuralgia);
• toothache;
• menstrual pain.

Paracetamolo Mylan Italia is indicated for the reduction of fever.

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking Paracetamol Mylan Italia

Do not take Paracetamol Mylan Italia

• if you are allergic to paracetamol, to other substances closely related to paracetamol from a chemical standpoint, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal failure);
• if you have been diagnosed with a disease characterized by glucose-6-phosphate dehydrogenase deficiency. Do not administer Paracetamol Mylan Italia to children weighing less than 26 kg (under 7 years of age).

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Mylan Italia:

• if your kidneys do not work properly (renal failure);
• if your liver does not work properly (hepatic failure) or if you suffer from a liver disease (including Gilbert's syndrome and hepatitis);
• if you have a serious infection (sepsis), as this may increase the risk of metabolic acidosis (increased production of acids by the body). Signs of metabolic acidosis may include:
• deep, rapid, difficult breathing
• nausea, vomiting
• loss of appetite. If a combination of these symptoms occurs, contact your doctor immediately;
• if you are pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Take special care with Paracetamol Mylan Italia:

• if an allergic reaction occurs: in this case, stop treatment and consult your doctor;
• if you have been diagnosed with glucose-6-phosphate dehydrogenase deficiency;
• if you suffer from haemolytic anaemia (reduction in the number of red blood cells);
• if you suffer from eating disorders (anorexia, bulimia);
• if you suffer from chronic malnutrition and cachexia (weight loss);
• if you consume excessive amounts of alcohol (3 or more alcoholic drinks per day);
• if you are alcohol-dependent (chronic alcoholism);
• if you are dehydrated;
• if you have reduced circulating blood volume (hypovolemia);
• do not take other medicines containing paracetamol at the same time: taking high doses of paracetamol may cause serious adverse effects;
• before combining with any other medicine, contact your doctor (read section "Other medicines and Paracetamol Mylan Italia");
• if you need to use this product at high doses or for a long period of time, as liver, kidney, or blood damage may occur; if you need to take the medicine for a prolonged period, your doctor may prescribe regular monitoring.

Children
Children weighing less than 26 kg (under 7 years of age) must not take this medicine.
Consult your doctor before administering this medicine to children aged between 7 and 12 years.
Other medicines and Paracetamol Mylan Italia
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
In particular, inform your doctor before taking Paracetamol Mylan Italia if you are taking the following medicines:

• medicines that slow down (e.g. propanteline) or increase (e.g. metoclopramide, domperidone) the rate of stomach emptying;
• non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines used to prevent blood clotting (e.g. warfarin and coumarin derivatives); in this case, your doctor will assess whether to reduce the dose of Paracetamol Mylan Italia;
• glutethimide, phenobarbital, carbamazepine, lamotrigine (medicines used to treat epilepsy);
• rifampicin (an antibiotic used to treat tuberculosis);
• cimetidine (a medicine used to treat gastric ulcers);
• chloramphenicol (a medicine used to treat infections);
• analgesic medicines used to treat pain (opioids);
• ethinylestradiol (a hormonal medicine often found in oral contraceptives);
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap) which must be treated urgently and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

Paracetamol Mylan Italia and alcohol
Take particular care when using paracetamol if you suffer from chronic alcoholism or consume excessive amounts of alcohol (3 or more alcoholic drinks per day).
Paracetamol Mylan Italia and laboratory tests
If you need to undergo blood tests to check your glucose or uric acid levels, make sure to inform your doctor that you are taking Paracetamol Mylan Italia.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
If necessary, Paracetamol Mylan Italia may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time.
Contact your doctor if pain and/or fever do not decrease or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol is excreted in small amounts in breast milk. Skin rashes have been reported in breastfed infants. However, administration of paracetamol is considered compatible with breastfeeding.
Driving and using machines
Be cautious if you need to drive vehicles or operate machinery, as Paracetamol Mylan Italia may cause dizziness.
Paracetamol Mylan Italia 500 mg granules contains sorbitol and aspartame

• Sorbitol: this medicine contains 94.5 mg of sorbitol per dose (1 sachet). Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which patients cannot properly metabolize fructose, speak with your doctor before you (or the child) take this medicine.
• Aspartame: this medicine contains 25 mg of aspartame per dose (1 sachet). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disease causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Paracetamol Mylan Italia

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest possible duration should be used to achieve clinical efficacy.
Place the granules directly on the tongue and swallow without water.

• In children, it is essential to follow the recommended dose based on body weight.
• In adults, the maximum recommended daily oral dose is 3000 mg.
• Do not take Paracetamol Mylan Italia for more than 3 consecutive days without consulting your doctor.
• Do not exceed the recommended doses.

The recommended dose of Paracetamol Mylan Italia according to body weight and route of administration is as follows (approximate ages, related to body weight, are provided for information only):

• Children weighing between 26 and 40 kg (approximately 8 to 12 years of age): 1 sachet at a time, which may be repeated if necessary after at least 6 hours, without exceeding 4 doses per day;
• Adolescents weighing between 41 and 50 kg (approximately 12 to 15 years of age): 1 sachet at a time, which may be repeated if necessary after at least 4 hours, without exceeding 6 doses per day;
• Adolescents weighing more than 50 kg (approximately over 15 years of age): 1 sachet at a time, which may be repeated if necessary after at least 4 hours, without exceeding 6 doses per day;
• Adults: 1 sachet at a time, which may be repeated if necessary after at least 4 hours, without exceeding 6 doses per day. In case of severe pain or high fever, 2 sachets of 500 mg may be taken, repeated if necessary after at least 4 hours.

Respect the minimum interval of 4 hours between two doses for adolescents and adults, and 6 hours between two doses for children weighing between 26 and 40 kg.
Children weighing less than 26 kg (under 7 years of age)
This medicine must not be administered to these patients.
Elderly patients
Your doctor will determine the appropriate dose and assess whether a reduction of the doses indicated above is necessary, based on your condition.
Renal impairment
This medicine is contraindicated in patients with severe kidney problems (severe renal impairment).
If you take more Paracetamol Mylan Italia than you should
If you accidentally take too much Paracetamol Mylan Italia, contact your doctor immediately or go to the nearest hospital.
If you have taken more than the recommended dose, you may experience the following symptoms, which usually appear within the first 24 hours:

• nausea;
• vomiting;
• loss of appetite;
• pallor;
• abdominal pain.
  In cases of overdose, paracetamol may cause liver failure, which may require liver transplantation or lead to death. Cases of acute pancreatitis associated with liver dysfunction and toxicity have also been observed. In case of overdose, consult your doctor or go to the nearest hospital, even in the absence of symptoms, because there is a risk of severe and irreversible liver damage, as well as potentially serious kidney and blood disorders, which may begin to manifest within 12–48 hours after ingestion.

If you forget to take Paracetamol Mylan Italia
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects of paracetamol listed below. There are insufficient data available to determine the frequency of the individual listed effects.

• Very rare cases of serious skin reactions (including cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
• allergic reactions such as, for example:
  o swelling (edema) of the larynx;
  o sudden swelling of the skin and mucous membranes (angioedema);
  o anaphylactic shock;
  o asthma;
  o skin rash (cutaneous rash).
• Reduction in the number of platelets (thrombocytopenia);
• reduction in the number of white blood cells (leukopenia);
• reduction in the number of red blood cells (anemia);
• reduction in the number of a type of white blood cells (agranulocytosis);
• liver function abnormalities and liver diseases (hepatitis);
• kidney-related disorders (acute renal failure);
• inflammation of the kidneys (tubulo-interstitial nephritis);
• blood in the urine (hematuria);
• reduced urine production (anuria);
• gastrointestinal reactions;
• dizziness;
• bronchospasm in subjects sensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (bronchospasm).
  Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamolo Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamolo Mylan Italia contains

• The active substance is paracetamol. Each sachet contains 500 mg of paracetamol.
• The other ingredients are mannitol, sorbitol (E420), aspartame (E951), citric acid, lemon flavor.

Description of the appearance of Paracetamolo Mylan Italia and contents of the pack
Paracetamolo Mylan Italia 500 mg is presented as a granulate.
Pack contents: 10 or 20 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano – Italy.
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 - 38123 Trento (TN)